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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic central control unit
Definition To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
Product CodeODA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BLACK DIAMOND VIDEO, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 2
SMITH+NEPHEW
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 2 2
Erratic or Intermittent Display 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 1 1

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